drugset / Trial / NCT03027193

A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers

NCT03027193 ↗

Phase 1 Completed 28 enrolled University of Oxford
Non-randomizedParallel-groupOpen-labelTreatment

Summary

A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccines ChAdOx2 HAV and MVA HAV in healthy volunteers. Volunteers will be recruited and vaccinated in Oxford, England. All vaccinations will be administered intramuscularly. Three different doses of the ChAdOx2 HAV will be tested (5x10\^9 vp, 2.5x10\^10 vp and 5x10\^10vp). MVA HAV will be assessed at 2 different doses (5x10\^7 and 2x10\^8 pfu) The total duration of the study will be 52 weeks from the day of enrolment for volunteers receiving ChAdOx2 HAV only, 12 weeks for volunteers receiving MVA HAV only and 20 weeks for volunteers receiving ChAdOx2 HAV and MVA HAV.

Timeline

Start
2017-03-15
Primary completion
2020-01-16
Completion
2020-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject ChAdOx2 HAV Vaccine 5e+09 unknown Intramuscular
Subject ChAdOx2 HAV Vaccine 2.5e+10 unknown Intramuscular
Subject ChAdOx2 HAV Vaccine 5e+10 unknown Intramuscular
Subject MVA HAV Vaccine 5e+07 unknown Intramuscular
Subject MVA HAV Vaccine 2e+08 unknown Intramuscular